The global medical device affairs outsourcing market revenue was around US$ 4.7 billion in 2021 and is estimated to reach US$ 8.4 billion by 2031, growing at a compound annual growth rate (CAGR) of 6% during the forecast period from 2022 to 2031.

Medical device affairs outstanding issues can take many different forms, ranging in size from a standalone service to a comprehensive solution. Regardless of the strategy, many businesses frequently look for outsourcing solutions to cut back on internal workers, prioritize strategic projects for internal resources, optimize the current team.s workload, centralize specific functions, and strengthen its oversight.

Factors Influencing Market Growth

- Medical device affairs outsourcing affairs aid in increasing the number of product registers and clinical trial approvals, which supports the market expansion.

- The emerging market's economic expansion creates a lucrative opportunity for the key players in the market.

- High expenses of product development and clinical testing, as well as regional medical device legislation changes. Such factors hamper the market growth.

Study of the COVID-19 Pandemic

The COVID-19 had a negative impact on the market. Due to the lockdown enacted by the government, many challenges for medical device businesses to make decisions about their supplies, supply chains, and regulatory duties while there is uncertainty. Professionals who work with medical devices have the unpleasant duty of requesting a break amidst the panic.

For instance, COVID-19's effects on clinical studies have been hindered because of difficulties brought on by travel prohibitions, limitations on visiting hospitals and clinics, and social distancing measures. These elements have resulted in a variety of problems that present difficulties concerning business milestones, finances, and data integrity. Any travel restrictions do not affect meetings or procedures. Meetings conduct remotely used video conferencing technology.

Regional Insights

Europe dominated the market in terms of the largest share. This is due to the region's abundance of clinical research organizations, strong key player presence, rising healthcare spending, higher rates of research, innovation & development activities, and higher adoption of cutting-edge technologies.

Moreover, Asia-Pacific is predicted to grow at the highest CAGR. This is due to a growth in the number of clinical trials being done and greater knowledge of the advantages of outsourcing regulatory affairs services.

Leading Competitors

The leading competitors in the global medical device affairs outsourcing market are:
- Thermo Fisher Scientific
- Inizio
- Parexel International Corporation
- WuXi AppTec
- Icon plc
- Charles River
- Excelya
- Syneos Health
- Indegene Private Limited
- SGS SA
- IQVIA Holdings Inc
- Others
Segmentation Analysis
The global medical device affairs outsourcing market segmentation focuses on Service, Software, End User, and Region.
Segmentation based on Service
- Regulatory Writing and Submissions
- Regulatory Registration Services
- Regulatory Consulting
- Others
Segmentation based on Software
- Cloud Based Software
- On Premise Software
Segmentation based on End User
- Pharmaceutical Companies
o Company Size
? Large
? Medium
- Medical Technology Companies
o Company Size
? Large
? Medium
- Others
Segmentation based on Region
- North America
- The U.S.
- Canada
- Mexico
- Europe
- Western Europe
- The UK
- Germany
- France
- Italy
- Spain
- Rest of Western Europe
- Eastern Europe
- Poland
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia & New Zealand
- ASEAN
- Rest of Asia Pacific

- Middle East & Africa (MEA)
- UAE
- Saudi Arabia
- South Africa
- Rest of MEA

- South America
- Brazil
- Argentina
- Rest of South America